Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate Versus Meglumine Antimoniate and Allopurinol
Information source: Combined Military Hospital, Pakistan
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leishmaniasis, Cutaneous
Intervention: meglumine antimoniate, allopurinol (Drug); meglumine antimoniate (Drug); meglumine antimoniate, allopurinol (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Combined Military Hospital, Pakistan Official(s) and/or principal investigator(s):
AMER EJAZ, FCPS, Principal Investigator, Affiliation: Combined Military Hospital, Pakistan
Overall contact:
AMER EJAZ, FCPS, Phone: 00 92 300 928 7063, Email: amer_ejaz@yahoo.com
Summary
Background: Cutaneous Leishmaniasis is a worldwide disease, endemic in over 88 countries,
that has shown an increasing incidence over the last many decades. For the last 60 years
antimony compounds are considered the treatment of choice. Though their use is expensive,
cumbersome, has many adverse effects and not effective in all patients, the search for a
better alternative is still going on. Low dose antimony compounds in combination with several
agents have shown promise of reducing adverse effects of antimony compounds without
compromising efficacy. Allopurinol is one such agent which though promising lacks randomized,
controlled trials to prove efficacy. The main objective of this study is to evaluate low dose
sodium stibogluconate in combination with allopurinol and to compare it with high dose sodium
stibogluconate in terms of efficacy and adverse effects.
Methods and design: A multi-center randomized, controlled trial including 620 patients from
endemic areas for Leishmaniasis in Pakistan will be undertaken to assess the research
question. Parasitologically confirmed cutaneous leishmaniasis will be included in the study.
After evaluating the inclusion/exclusion criteria patients will be randomized to receive
either meglumine antimoniate (20 mg/kg/day/intramuscular, till clinical resolution or a
maximum of 28 days) or combination of meglumine antimoniate (10 mg/kg/day intramuscular) and
allopurinol (20 mg/kg/day/oral) till clinical resolution or a maximum of 28 days. During
treatment patients will be admitted to hospital and monitored daily for the presence of
adverse effects. Follow up period will last six months during which patients will visits the
research centers for assessment of healing process at monthly intervals.
Clinical Details
Official title: Treatment of Cutaneous Leishmaniasis With Meglumine Antimoniate 20 Mg/Kg/Day Versus Meglumine Antimoniate 10 Mg/Kg/Day And Tablet Allopurinol 20 Mg/Kg/Day
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: clinical healing of lesions.
Secondary outcome: improvement of more than 50% in lesion size
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men and women between 18 and 50 years old.
- Cutaneous ulcers, nodules, plaques, of more than two weeks of evolution requiring
systemic therapy.
- Positive parasitological diagnosis for cutaneous leishmaniasis.
- Patients that voluntarily accept to participate in the study and sign the informed
consent.
- Disposition to be admitted to hospital, if necessary, and to attend all the visits
punctually (initial, treatment and follow up).
- Acceptation of not using any other treatment for cutaneous leishmaniasis while in the
study.
Exclusion Criteria:
- Pregnant women.
- Presence of any condition or disease that compromises the patient immunologically
(i. e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the
researcher, could alter the course of cutaneous leishmaniasis.
- Diffuse cutaneous leishmaniasis.
- Visceral leishmaniasis.
- Complete or incomplete treatment with antimony compounds in the last three months.
- Patients with history of hepatic, renal, or cardiovascular disease.
- Mentally or neurologically disabled patients that are considered not fit to approve
their participation in the study.
Locations and Contacts
AMER EJAZ, FCPS, Phone: 00 92 300 928 7063, Email: amer_ejaz@yahoo.com
Combined Military Hospital, KHARIAN CANTONMENT, PUNJAB 74400, Pakistan; Recruiting
AMER EJAZ, Phone: 00 92 300 928 7063, Email: amer_ejaz@yahoo.com
Additional Information
Related publications: Momeni AZ, Reiszadae MR, Aminjavaheri M. Treatment of cutaneous leishmaniasis with a combination of allopurinol and low-dose meglumine antimoniate. Int J Dermatol. 2002 Jul;41(7):441-3.
Starting date: January 2008
Ending date: December 2008
Last updated: May 6, 2008
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